Lactobacillus Reuteri for Non-surgical Periodontal Treatment of Chronic Periodontitis With Type 2 Diabetes Patients

NCT05275803 | Unknown

• 1 other identifier: DHZhejiangU-2022(025)
• Study Type: interventional
• Target: 48
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study aims to investigate the clinical and microbiological efficacy of Lactobacillus reuteri as an adjunctive therapy to non-surgical periodontal treatment of chronic periodontitis with type 2 diabetes.

Conditions

Periodontitis

Outcome Measures

Primary Outcomes (2)

• Probing depth

  measured at six sites of each implant (mesio-labial/buccal, mid-labial/buccal, disto-labial/buccal, mesio-palatal/lingual, mid-palatal/lingual, and disto-palatal/lingual) using a periodontal probe (UNC15)

  change from baseline to day 90

• Microorganism

  measured by 16s rDNA in subgingival plaque and faces

  change from baseline to day 90

Secondary Outcomes (6)

• Gingival index

  day 0, 30, 90, 150

• Gingival Recession

  day 0, 30, 90, 150

• Bleeding of Probing

  day 0, 30, 90, 150

• Fasting Blood Glucose

  day 0, 30, 90, 150

• HbA1c

  day 0, 30, 90, 150

Study Arms (2)

Probiotics

EXPERIMENTAL

The participants would use probiotics for 30 days

Dietary Supplement: Probiotics

Control

EXPERIMENTAL

The participants would use not probiotics

Dietary Supplement: Control

Interventions

Probiotics DIETARY_SUPPLEMENT

The participant would receive non-surgical periodontal treatment, after which the participant uses probiotics (BioGaia Prodentis, L. reuteri DSM 17938+L. reuteri ATCC 5289, 0.8g, qn) for another 30 days.

Probiotics

Control DIETARY_SUPPLEMENT

The participant does not use probiotics after non-surgical periodontal treatment.

Control

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age between 35 to 70 years,
• type 2 diabetes with treatment ≥ 6-month, with HbA1c≤7.5%,
• generalized periodontitis (Stage III or IV),
• no less than 15 teeth

You may not qualify if:

• smoking, or quit smoking for less than 5 years;
• Suffering from other known systemic diseases that can affect the progression of periodontitis (immune abnormalities, osteoporosis, history of head and neck radiotherapy, etc.);
• Received periodontal treatment within 6 months;
• Have taken antibiotics, non-steroidal anti-inflammatory drugs, immunosuppressants, hormones and other drugs that affect periodontal within 3 months;
• Have taken probiotics within 6 months;
• Prophylactic use of antibiotics is required;
• Pregnant and lactating women;

Sponsors & Collaborators

• The Dental Hospital of Zhejiang University School of Medicine: lead

MeSH Terms

Conditions

Periodontitis

Interventions

Probiotics

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary Supplements; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 2, 2022
• First Posted: March 11, 2022
• Study Start: June 8, 2023
• Primary Completion: June 20, 2023
• Study Completion: May 20, 2024
• Last Updated: June 7, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share